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New camera tech could spot preterm birth risk early

NCT ID NCT04661553

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a special camera (Mueller polarimetric colposcopy) to see if it can measure changes in the cervix during pregnancy. The goal is to find patterns that could help predict if a baby will be born early (preterm). Researchers will study 683 pregnant women, both with low and high risk of preterm birth, to identify the best measurements. This is an observational study, not a treatment, so it aims to improve how we detect preterm birth risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 683 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Major patient. * Single pregnancy. * Baseline ≥ 20 amenorrhea week for group 1 and baseline ≥ 20 amenorrhea week and \<37 amenorrhea week for group 2. * Dating obtained by ultrasound of the 1st trimester. * Written and informed consent. * Group 1 (low risk): Asymptomatic patient benefiting from usual follow-up in the maternity hospital. \> Group 2 (high risk): Symptomatic patient with cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of \<20mm. Asymptomatic patient with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of \<20mm." Exclusion Criteria: * Known uterine malformation or suspected uterine malformation. * Pregnancy circled. * Premature rupture of membranes. * Suspicion of chorioamnionitis. * Abundant active bleeding hindering the visualization of the cervix. * History of conization. * Imminent childbirth. * Known medical indication at a birth \<37 amenorrhea week (severe pre-eclampsia, severe intrauterine growth retardation, hemorrhagic placenta previa, fetal malformations,….). * Examination of the cervix under speculum not possible. * Lack of social coverage (AME). * Limited understanding. * Participation in another intervention research. \> Group1 (Low risk): * History of spontaneous premature labor. * History of late miscarriage. * History of premature rupture of membranes."

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Conditions

The condition(s) this trial relates to.

pregnancy disorder Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnancy related Premature birth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Bicêtre - Gynecology-Obstetrics Department

    RECRUITING

    Le Kremlin-Bicêtre, France, 94275, France

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Other studies related to the condition(s) this trial covers.